Job Description

The purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients.



Headquartered in Switzerland - a biotech-hub of Europe - Idorsia is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.



We are looking for a

Senior Director, Head of QA Commercial Affiliates

to join our team !

Job Responsibilities

Developing a scalable, proactive commercial Quality organization anticipating future needs in Europe, US and other countries which includes oversight of commercial related GMP/ GDP/ PV activities Develop and lead the commercial QA affiliate representatives at Idorsia affiliates Obtaining and maintaining the required licenses in the different countries in order to support launches and subsequent commercial activities worldwide Setting goals to support Quality and Corporate needs. Support and Represent Idorsia Quality during inspections and / or during discussions with HA's and with senior level leaders at Contract Organizations in Europe. Manage performance and development of direct reports and consultants to ensure achievement of organizational and department goals and a productive environment. Negotiate and manage quality agreements. Lead teams in the execution of quality targets and goals. Develop and roll out the Idorsia QMS to affiliates Help ensure quality of products produced / maintained at CMOs Participate in external/ internal audits, if relevant Perform audits and self-inspections Act as QP or deputy QP in case needed Hiring and developing the best talent. Continuous improvement of Quality system Drives changes and lean activities to foster a Q culture and to continuously improve Q performance of the site Leading, coaching, and mentoring employees in QA to build high performance teams Ensures appropriate management of regulatory agency inspections and other health authorities requests to obtain and maintain operating licenses in area of responsibility Interface with senior management to discuss quality and compliance issues Interface between RPs and QPs to align on processes and discuss quality and compliance issues Help ensure activities and deliverables are in compliance with Swissmedic, FDA, EMA, German, UK, Italian, Spanish, Swedish, Dutch, Austrian and other global and national European regulations and guidances, ICH guidelines, Idorsia policies, SOP's and industry best practices. The following experiences would see as a strong Advantage: + experience as

Qualified Person (QP) in the European Economic Area (EEA)

+ experience as

Responsible Person (RP, Fachtechnisch verantwortliche Person, FvP)

in Switzerland
+ experience as

Responsible Person (GDP-RP, Verantwortliche Person fur den Gro

?

handel)

Candidate's Requirements

A Master's degree or equivalent in a scientific discipline (Pharmacy, Biology, Chemistry, Biochemistry) required; an advanced degree is a plus. Minimum of 10 years of experience leading in pharmaceutical industry. Minimum of 5 years of experience leading in Quality Assurance. Demonstrated ability to influence and maintain a quality culture. Flexibility and the ability to manage change while accomplishing goals. Knowledge of global cGMP's and GDP, with a high focus on knowledge of Swiss and European Union laws and ordinances. Knowledge and experience managing CMOs preferred. Strong interpersonal skills and the ability to work well as part of a team. Exceptional verbal and written communication skills. Demonstrated ability for analytical and systematic thinking. Fosters an environment of accountability, diversity and speaking up Ability to manage budget, resourcing and to lead a department Strong leadership skills with a proven record of leading and motivating staff and teams. Registered as a Swiss Responsible Person and Qualified Person as per Annex 16. Fulfill legal requirements like education, expertise and experience to get registered as QP and GDP-RP Experience as lead auditor

What Idorsia offers

Home-Office possibility A collaborative and solution-oriented environment where you can make a difference An innovative and open culture in a truly multicultural environment A competitive salary and generous social benefits

Work Location:

Allschwil - Basel Area

Country:

Switzerland

Business Area:

Global Quality Assurance

Schedule:

Fulltime

Job Type:

Permanent

Job ID:

4608

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.




Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.




Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.